Amarin's (AMRN) Vascepa in Difficult Spot, Thinks Summer Street

November 22, 2013 10:51 AM EST Send to a Friend
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On November 21, 2013, Amarin (Nasdaq: AMRN) received notification from the dispute resolution group of the Office of New Drugs at the FDA that it has not accepted for review, on procedural grounds, Amarin's appeal. The news relates to SPA for Vascepa regarding the treatment of patients with moderate triglycerides.

Commenting, Summer Street analyst Bart Classen said, "We believe that Amarin has almost no chance of getting the FDA to approve Vascepa for treating moderate triglycerides without outcomes data. However we believe that a positive outcome trial is a long shot because no agent has ever shown an outcome benefit over statins."

Amarin is Not Rated by Summer Street.

For an analyst ratings summary and ratings history on Amarin Corporation click here. For more ratings news on Amarin Corporation click here.

Shares of Amarin Corporation closed at $1.99 yesterday.


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Analyst Comments, FDA

Comments

FDA needs to be investigated
ralph on 2013-11-22 15:01:35
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· The FDA could not reject Vascepa based on safety or efficacy so most amazingly they temporarily rejected all existing standards of care indicating that Triglycerides between 200- 500 mg/dl not be treated. This groundbreaking information was never given to practitioners who continued to prescribe billions of dollars of medication to treat Triglycerides in the 200 – 500 mg dl range. The only public notification of this groundbreaking news was in an SEC Form 8-K to AMARIN investors.
· The FDA prevented the most compelling evidence regarding lowering of cardiovascular outcomes with EPA (Jelis Study) from being presented to the ADCOM committee
· After meeting all of the agreed upon ANCHOR endpoints the FDA amazingly changed the requirements at the ADCOM meeting and asked the panel to predict the results of a future study.
· The FDA then indicated to the general public that trans-fatty acids – most of which are converted to Triglycerides in the body should be reduced. In direct contradiction to their statement that triglyceride levels in the 200- 500 mg / dl range should not be treated.
· The FDA then approved a drug that lowers Triglycerides (Antara) and approved their label, which states that lowering Triglycerides has no effect on cardiovascular outcomes – the very reason they rejected Vascepa!
· The FDA’s website still indicates that triglyceride > 200 mg / dl be treated
· The FDA indicates to Amgen and Sanofi that their new PCSK9 drugs do not need to prove they prevent heart attacks and death before they’re approved…. But Vascepa does !
· OTC Fish oil which only contains a fraction of EPA, the FDA approved label says, it MAY reduce heart disease yet the concentrated form apparently does nothing according to the FDA


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